Clinical Research Nurse, Clinical Trial Support Unit

Clinical Research Nurse, Clinical Trial Support Unit

Primary Purpose : The Clinical Research Nurse’s primary purpose is to proficiently assist the Principal Investigator and research team by providing research coordination and support.

Success in the role will require some judgment and decision making and following research regulations, as well as procedures and guidelines set by the PI and collaborating with the research team.

Nature of Work : The CRN reports to the Director of Research and is accountable to the PI. The position is responsible for coordinating clinical studies, which encompasses research related nursing and administrative tasks within the PIs research program.

The CRN will follow nursing standards in compliance with the College of Nurses and the Regulated Health Professionals Act when performing per protocol procedures.

The ability to effectively work through complex issues and concerns with low to moderate stress resulting from work pressure is necessary.

Strong communication, organizational, analytical, and problem-solving skills are required. The ability to work well as a team member is critical to the role.

The position may involve field work and irregular hours, such as weekend and evening work.

Accountabilities :

• Coordinates and executes study visits per protocol
• Ensures per protocol tasks are completed as per the schedule of assessments
• Ensures a safe environment for research participants and staff
• Acts as the primary contact and provides support for research
• Establishes and maintains strong working relationships with participants, researchers, and other study personnel; Liaises between study sponsors, staff, investigators and the CTSU
• Maintains organization and proper documentation of research materials
• Demonstrate a commitment to teamwork and positivity, along with an ability to create and nurture positive working relationships.

Duties : Study Set-up

Study Set-up

• Participates in site pre-qualification and qualification efforts
• Ensures all required approvals are in place prior to enrollment
• Recruits research participants and conducts eligibility assessment

Study Execution

• Coordinates per protocol procedures for study visits
• Performs per protocol study procedures including administering questionnaires and assessments,
• Prepare, dispense, and administer study drug per protocol
• Perform venipuncture, phlebotomy, insertion of IV-lines
• Perform ECGs and vital signs collection and assessment
• Process study samples and store or distribute for analyses
• Creates and maintains accurate patient source documents ensuring GCP
• Participates in Health Canada inspections and sponsor audits

Study Close-out

Prepares and submits case report forms in compliance with SOPs and regulations

Research Administration

• Assists with monitoring and ordering of study specific supplies
• Attends meetings including investigator, site initiation / close out, and monitoring visits
• Provides orientation and training to research staff on relevant policies, procedures, standards, and regulations

Qualifications :

Education and Experience : A Bachelor’s degree in Nursing or completion of an applicable nursing education program. Experience in clinical research would be considered an asset.

Must be registered or eligible for registration with the Saskatchewan Registered Nurse’s Association.

Required Skills :

• Proficiency with Microsoft Office (Word, Excel, Outlook)
• Excellent verbal and written communication skills
• Strong organizational, time, and project management skills
• Excellent interpersonal and ability to collaborate with team members
• Detail oriented and able to exercise initiative and good judgement

Training : The following certifications are required prior to commencing any study related procedures

• TCPS2 Core Course
• Safety Orientation for Employees (USask)
• Off-Campus Activity Safety Plans (USask)
• Canada GCP (CITI)
• Clinical Research Coordinator (CITI)
• Health Canada Division 5 (CITI)
• Protocol Specific SOPs (N2)
6 days ago